[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100611542":3},{"organization":4,"outcomesModule":7,"designInfo":17,"detailedDescription":11,"studyPopulation":11,"armGroups":24,"interventions":43,"overallOfficials":11,"centralContacts":61,"locations":67,"responsibleParty":84,"collaborators":11,"id":86,"slug":11,"hasResults":87,"nctId":88,"briefTitle":89,"officialTitle":90,"acronym":11,"eligibilityCriteria":91,"healthyVolunteers":87,"sex":92,"minAge":93,"maxAge":94,"enrollmentInfo":95,"targetDuration":11,"studyType":98,"phases":99,"briefSummary":102,"conditions":103,"keywords":11,"overallStatus":70,"whyStopped":11,"lastUpdateSubmitDate":105,"lastUpdatePostDateStruct":106,"startDateStruct":109,"completionDateStruct":111,"leadSponsor":113,"locationsCount":114},{"fullName":5,"class":6},"CSPC ZhongQi Pharmaceutical Technology Co., Ltd.","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":11,"otherOutcomes":11},[9,13,15],{"measure":10,"description":11,"timeFrame":12},"The occurrence and frequency of adverse events (AE) and serious adverse events (SAE)",null,"Up to approximately 36 weeks after the first participant is enrolled",{"measure":14,"description":11,"timeFrame":12},"dose - limiting toxicities (DLT)",{"measure":16,"description":11,"timeFrame":12},"The recommended phase 2 dose",{"allocation":18,"interventionModel":19,"interventionModelDescription":20,"primaryPurpose":21,"observationalModel":11,"timePerspective":11,"maskingInfo":22},"NON_RANDOMIZED","PARALLEL","Dose escalation and expansion","TREATMENT",{"masking":23,"maskingDescription":11,"whoMasked":11},"NONE",[25,31,35,39],{"label":26,"type":27,"description":11,"interventionNames":28},"sirolimus (albumin-bound)+ DP303c","EXPERIMENTAL",[29,30],"Drug: sirolimus (albumin-bound)","Drug: DP303c",{"label":32,"type":27,"description":11,"interventionNames":33},"sirolimus (albumin-bound)+ SYS6043",[29,34],"Drug: SYS6043",{"label":36,"type":27,"description":11,"interventionNames":37},"sirolimus (albumin-bound)+ SYS6002",[29,38],"Drug: SYS6002",{"label":40,"type":27,"description":11,"interventionNames":41},"sirolimus (albumin-bound)+ SYS6010",[29,42],"Drug: SYS6010",[44,49,52,55,58],{"type":45,"name":46,"description":47,"armGroupLabels":48,"otherNames":11},"DRUG","sirolimus (albumin-bound)","intravenous infusion",[26,36,40,32],{"type":45,"name":50,"description":47,"armGroupLabels":51,"otherNames":11},"DP303c",[26],{"type":45,"name":53,"description":47,"armGroupLabels":54,"otherNames":11},"SYS6043",[32],{"type":45,"name":56,"description":47,"armGroupLabels":57,"otherNames":11},"SYS6002",[36],{"type":45,"name":59,"description":47,"armGroupLabels":60,"otherNames":11},"SYS6010",[40],[62],{"name":63,"role":64,"phone":65,"phoneExt":11,"email":66},"Clinical Trials Information Group officer","CONTACT","86-0311-69085587","ctr-contact@cspc.cn",[68],{"facility":69,"status":70,"city":71,"state":11,"zip":11,"country":72,"countryCode":73,"cosmosGeoPoint":74,"geoPoint":79,"contacts":80},"Fudan University Shanghai Cancer Center","RECRUITING","Shanghai","China","CN",{"type":75,"coordinates":76},"Point",[77,78],121.45806,31.22222,{"lat":78,"lon":77},[81],{"name":82,"role":64,"phone":11,"phoneExt":11,"email":83},"Jian Zhang","syner2000@163.com",{"type":85,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100611542",false,"NCT07241936","A Study of Sirolimus (Albumin-Bound) in Combination With Different ADCs Treatment of Advanced Solid Tumors","A Phase Ib\u002FII Clinical Trial on the Safety and Efficacy of Sirolimus (Albumin-bound) Combined With Different ADCs in Patients With Advanced Solid Tumors","Inclusion Criteria:\n\n* 1\\. Subjects aged 18 to 75 years (inclusive).\n* 2\\. Patients with advanced solid tumors that are unresectable or metastatic and confirmed by histology or cytology.\n* 3\\. At least one measurable lesion, as defined by RECIST 1.1 criteria.\n* 4\\. ECOG performance status of 0 or 1.\n* 5\\. Expected survival ≥ 3 months.\n* 6\\. Adequate function of major organs and bone marrow.\n* 7\\. Willing to provide samples of previously removed tumors or undergo fresh tumor biopsy.\n* 8\\. Women or man of childbearing potential must use highly effective contraception.\n* 9\\. Able to understand and voluntarily sign the written informed consent form (ICF).\n\nExclusion Criteria:\n\n* 1\\. Previous use of antibody-conjugated drugs with similar loading agents for treatment.\n* 2\\. Previous anti-tumor treatment drugs were not adequately removed.\n* 3\\. Active leptomeningeal disease or uncontrolled CNS metastasis.\n* 4\\. Having a history of severe or uncontrolled cardiovascular or cerebrovascular diseases.\n* 5\\. Previous interstitial lung disease requiring glucocorticoid treatment, Or currently suffering from interstitial lung disease\u002Fnon-infectious pneumonia, or the imaging examination during the screening period cannot rule out interstitial pneumonia\u002Flung disease.\n* 6\\. Patients who developed severe and moderately severe lung diseases that significantly affected lung function within 6 months of the first medication administration; patients requiring supplementary oxygen therapy.\n* 7\\. Individuals who currently have eye diseases such as corneal disorders, retinal disorders, or active ocular infections that require intervention, or who have a history of serious corneal-related eye diseases in the past; or who are unwilling to stop wearing corneal contact lenses during the study; or who have other existing eye diseases that affect the assessment of ocular toxicity after the administration of the investigational drug.\n* 8\\. Currently suffering from skin diseases that require oral or intravenous medication treatment.\n* 9\\. Had a history of ulcerative colitis or Crohn's disease.\n* 10\\. Within 14 days prior to the first administration of the medication, there is a need for systemic antibacterial, antifungal or antiviral treatment for severe chronic or active infections, and there is no cure for active tuberculosis.\n* 11\\. Known to be allergic to any component of the test drug, or allergic to the humanized monoclonal antibody product.\n* 12\\. Participants with poor compliance.","ALL","18 Years","75 Years",{"count":96,"type":97},444,"ESTIMATED","INTERVENTIONAL",[100,101],"PHASE1","PHASE2","This study adopts a multi-center, open-label, non-randomized trial design. It plans to enroll patients with Advanced solid tumor. Dose-escalation and PK-expansion studies will be carried out to evaluate the safety, tolerability, and preliminary efficacy of sirolimus (albumin-bound) in combination with Different ADCs (DP303c\u002FSYS6043\u002FSYS6002\u002FSYS6010) in this patient population, and to confirm the recommended phase 2 dose (RP2D).",[104],"Advanced Solid Tumors","2025-11-21",{"date":107,"type":108},"2025-11-28","ACTUAL",{"date":110,"type":108},"2025-11-13",{"date":112,"type":97},"2028-10-30",{"name":5,"class":6},1]